81 FR 81785 - Use of The Seafood List To Determine Acceptable Seafood Names; Draft Compliance Policy Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 223 (November 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 223 (November 18, 2016)
| Page Range | 81785-81786 | |
| FR Document | 2016-27843 |
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)] [Notices] [Pages 81785-81786] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27843] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-3004] Use of The Seafood List To Determine Acceptable Seafood Names; Draft Compliance Policy Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for FDA staff entitled ``Compliance Policy Guide Sec. 540.750 Use of The Seafood List to Determine Acceptable Seafood Names'' (the draft Compliance Policy Guide (CPG)). The draft CPG, when finalized, will provide guidance for FDA staff regarding use of The Seafood List to determine whether a seafood name is acceptable. DATES: Although you can comment on any CPG at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft CPG before we begin work on the final version of the CPG, submit either electronic or written comments on the draft CPG by January 17, 2017. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-D-3004 for ``Compliance Policy Guide Sec. 540.750 Use of The Seafood List to Determine Acceptable Seafood Names.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the [[Page 81786]] information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft CPG to the Food and Feed Policy Staff, Office of Policy and Risk Management, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft CPG. FOR FURTHER INFORMATION CONTACT: Spring C. Randolph, Center for Food Safety and Applied Nutrition (HFC-325), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1421. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of the draft CPG entitled ``Compliance Policy Guide Sec. 540.750 Use of The Seafood List to Determine Acceptable Seafood Names.'' The draft CPG, if finalized, will update the previously issued ``CPG Sec. 540.750--Common or Usual Names for Seafood in Interstate Commerce.'' The draft CPG is intended to provide guidance for FDA staff regarding use of The Seafood List to determine whether a seafood name is acceptable. The draft CPG explains when we may consider a seafood product to be misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343). The draft CPG also contains information that may be useful to the regulated industry and to the public. We are issuing this draft CPG consistent with our good guidance practices regulation (21 CFR 10.115). The draft CPG, when finalized, will represent our current thinking on acceptable names for seafood in interstate commerce. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons with access to the Internet may obtain the draft CPG from FDA's Office of Regulatory Affairs CPG history page at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: November 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-27843 Filed 11-17-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices 81785
premarket notifications for new review by the Office of Management and Electronic Submissions
magnetic resonance imaging (MRI) and Budget (OMB) under the Paperwork Submit electronic comments in the
magnetic resonance spectroscopy Reduction Act of 1995 (44 U.S.C. 3501– following way:
systems, components, and accessories, 3520). The collections of information in • Federal eRulemaking Portal: http://
and modifications to systems, 21 CFR part 807, subpart E (premarket www.regulations.gov. Follow the
components, and accessories that could notification), have been approved under instructions for submitting comments.
significantly affect the safety or OMB control number 0910–0120; the Comments submitted electronically,
effectiveness of the MRDD. The collections of information in 21 CFR including attachments, to http://
information in this guidance document part 801 (labeling) have been approved www.regulations.gov will be posted to
is also applicable to the MRI system under OMB control number 0910–0485; the docket unchanged. Because your
components of dual-modality devices, the collections of information in parts comment will be made public, you are
such as positron emission tomography/ 1002 through 1050 (electronic product solely responsible for ensuring that your
MRI systems. requirements) have been approved comment does not include any
In the Federal Register of July 14, under OMB control number 0910–0025; confidential information that you or a
2015 (80 FR 41046), FDA announced the and the collections of information in the third party may not wish to be posted,
availability of the draft guidance and guidance document ‘‘Requests for such as medical information, your or
interested persons were invited to Feedback on Medical Device anyone else’s Social Security number, or
comment by October 13, 2015. FDA has Submissions: The Pre-Submission confidential business information, such
considered the comments received, and Program and Meetings with Food and as a manufacturing process. Please note
has incorporated changes suggested by Drug Administration Staff’’ have been that if you include your name, contact
the comments, as appropriate. approved under OMB control number
This guidance supersedes FDA’s information, or other information that
0910–0756. identifies you in the body of your
guidance entitled ‘‘Guidance for
Industry: Guidance for the Submissions
Dated: November 15, 2016. comments, that information will be
of Premarket Notifications for Magnetic Leslie Kux, posted on http://www.regulations.gov.
Associate Commissioner for Policy. • If you want to submit a comment
Resonance Diagnostic Devices’’ dated
with confidential information that you
November 14, 1998. [FR Doc. 2016–27842 Filed 11–17–16; 8:45 am]
do not wish to be made available to the
BILLING CODE 4164–01–P
II. Significance of Guidance public, submit the comment as a
This guidance is being issued written/paper submission and in the
consistent with FDA’s good guidance DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
practices regulation (21 CFR 10.115). HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
The guidance represents the current Written/Paper Submissions
thinking of FDA on ‘‘Submission of Food and Drug Administration
Premarket Notifications for Magnetic Submit written/paper submissions as
Resonance Diagnostic Devices.’’ It does follows:
[Docket No. FDA–2016–D–3004]
not establish any rights for any person • Mail/Hand delivery/Courier (for
and is not binding on FDA or the public. Use of The Seafood List To Determine written/paper submissions): Division of
You can use an alternative approach if Acceptable Seafood Names; Draft Dockets Management (HFA–305), Food
it satisfies the requirements of the Compliance Policy Guide; Availability and Drug Administration, 5630 Fishers
applicable statutes and regulations. Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, • For written/paper comments
III. Electronic Access submitted to the Division of Dockets
HHS.
Persons interested in obtaining a copy Management, FDA will post your
of the guidance may do so by ACTION: Notice of availability. comment, as well as any attachments,
downloading an electronic copy from except for information submitted,
the Internet. A search capability for all SUMMARY: The Food and Drug marked and identified, as confidential,
Center for Devices and Radiological Administration (FDA or we) is if submitted as detailed in
Health guidance documents is available announcing the availability of a draft ‘‘Instructions.’’
at http://www.fda.gov/MedicalDevices/ guidance for FDA staff entitled Instructions: All submissions received
DeviceRegulationandGuidance/ ‘‘Compliance Policy Guide Sec. 540.750 must include the Docket No. FDA–
GuidanceDocuments/default.htm. Use of The Seafood List to Determine 2016–D–3004 for ‘‘Compliance Policy
Guidance documents are also available Acceptable Seafood Names’’ (the draft Guide Sec. 540.750 Use of The Seafood
at http://www.regulations.gov. Persons Compliance Policy Guide (CPG)). The List to Determine Acceptable Seafood
unable to download an electronic copy draft CPG, when finalized, will provide Names.’’ Received comments will be
of ‘‘Submission of Premarket guidance for FDA staff regarding use of placed in the docket and, except for
Notifications for Magnetic Resonance The Seafood List to determine whether those submitted as ‘‘Confidential
Diagnostic Devices’’ may send an email a seafood name is acceptable. Submissions,’’ publicly viewable at
request to CDRH-Guidance@fda.hhs.gov http://www.regulations.gov or at the
DATES: Although you can comment on
to receive an electronic copy of the Division of Dockets Management
any CPG at any time (see 21 CFR
document. Please use the document between 9 a.m. and 4 p.m., Monday
10.115(g)(5)), to ensure that we consider
through Friday.
mstockstill on DSK3G9T082PROD with NOTICES
number 340 to identify the guidance your comment on the draft CPG before
you are requesting. • Confidential Submissions—To
we begin work on the final version of
submit a comment with confidential
IV. Paperwork Reduction Act of 1995 the CPG, submit either electronic or
information that you do not wish to be
written comments on the draft CPG by
This guidance refers to previously made publicly available, submit your
January 17, 2017.
approved collections of information comments only as a written/paper
found in FDA regulations. These ADDRESSES: You may submit comments submission. You should submit two
collections of information are subject to as follows: copies total. One copy will include the
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![81786 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices
information you claim to be confidential Usual Names for Seafood in Interstate ADDRESSES: The meeting will be held in
with a heading or cover note that states Commerce.’’ The draft CPG is intended the Democracy 2 Building at 6707
‘‘THIS DOCUMENT CONTAINS to provide guidance for FDA staff Democracy Blvd., Bethesda, MD, in
CONFIDENTIAL INFORMATION.’’ The regarding use of The Seafood List to Conference Room 7050.
Agency will review this copy, including determine whether a seafood name is FOR FURTHER INFORMATION CONTACT: For
the claimed confidential information, in acceptable. The draft CPG explains further information concerning this
its consideration of comments. The when we may consider a seafood meeting, see the DMICC Web site,
second copy, which will have the product to be misbranded under section www.diabetescommittee.gov, or contact
claimed confidential information 403 of the Federal Food, Drug, and Dr. B. Tibor Roberts, Executive
redacted/blacked out, will be available Cosmetic Act (21 U.S.C. 343). The draft Secretary of the Diabetes Mellitus
for public viewing and posted on http:// CPG also contains information that may Interagency Coordinating Committee,
www.regulations.gov. Submit both be useful to the regulated industry and National Institute of Diabetes and
copies to the Division of Dockets to the public. Digestive and Kidney Diseases, 31
Management. If you do not wish your We are issuing this draft CPG Center Drive, Building 31A, Room
name and contact information to be consistent with our good guidance 9A19, MSC 2560, Bethesda, MD 20892–
made publicly available, you can practices regulation (21 CFR 10.115). 2560, telephone: 301–496–6623; FAX:
provide this information on the cover The draft CPG, when finalized, will 301–480–6741; email: dmicc@
sheet and not in the body of your represent our current thinking on mail.nih.gov.
comments and you must identify this acceptable names for seafood in
SUPPLEMENTARY INFORMATION: The
information as ‘‘confidential.’’ Any interstate commerce. It does not
establish any rights for any person and DMICC and the UICC, both chaired by
information marked as ‘‘confidential’’ the National Institute of Diabetes and
will not be disclosed except in is not binding on FDA or the public.
You can use an alternate approach if it Digestive and Kidney Diseases (NIDDK)
accordance with 21 CFR 10.20 and other comprising members of the Department
applicable disclosure law. For more satisfies the requirements of the
applicable statutes and regulations. of Health and Human Services and other
information about FDA’s posting of federal agencies that support diabetes-
comments to public dockets, see 80 FR II. Electronic Access related or urologic-related activities
56469, September 18, 2015, or access respectively, facilitate cooperation,
Persons with access to the Internet
the information at: http://www.fda.gov/ communication, and collaboration on
may obtain the draft CPG from FDA’s
regulatoryinformation/dockets/ diabetes among government entities.
Office of Regulatory Affairs CPG history
default.htm. The Committees’ meetings, held several
page at http://www.fda.gov/ICECI/
Docket: For access to the docket to times a year, provide an opportunity for
ComplianceManuals/CompliancePolicy
read background documents or the their members to learn about and
GuidanceManual/default.htm or http://
electronic and written/paper comments discuss current and relevant future
www.regulations.gov. Use the FDA Web
received, go to http:// site listed in the previous sentence to programs in their member organizations
www.regulations.gov and insert the find the most current version of the and to identify opportunities for
docket number, found in brackets in the guidance. collaboration. The December 16, 2016
heading of this document, into the joint meeting will focus on The Urologic
‘‘Search’’ box and follow the prompts Dated: November 15, 2016.
Leslie Kux,
Complications of Diabetes.
and/or go to the Division of Dockets Any member of the public interested
Management, 5630 Fishers Lane, Rm. Associate Commissioner for Policy.
in presenting oral comments to the
1061, Rockville, MD 20852. [FR Doc. 2016–27843 Filed 11–17–16; 8:45 am] Committees should notify the contact
Submit written requests for single BILLING CODE 4164–01–P person listed on this notice at least 10
copies of the draft CPG to the Food and days in advance of the meeting.
Feed Policy Staff, Office of Policy and Interested individuals and
Risk Management, Office of Regulatory DEPARTMENT OF HEALTH AND representatives or organizations should
Affairs, Food and Drug Administration, HUMAN SERVICES
submit a letter of intent, a brief
12420 Parklawn Dr., Rockville, MD description of the organization
20857. Send two self-addressed National Institutes of Health
represented, and a written copy of their
adhesive labels to assist that office in Notice of Joint Meeting by the Urology oral presentation in advance of the
processing your request. See the Interagency Coordinating Committee meeting. Only one representative of an
SUPPLEMENTARY INFORMATION section for organization will be allowed to present;
and the Diabetes Mellitus Interagency
electronic access to the draft CPG. Coordinating Committee Meeting oral comments and presentations will be
FOR FURTHER INFORMATION CONTACT: limited to a maximum of 5 minutes.
Spring C. Randolph, Center for Food SUMMARY: The Diabetes Mellitus Printed and electronic copies are
Safety and Applied Nutrition (HFC– Interagency Coordinating Committee requested for the record. In addition,
325), Food and Drug Administration, (DMICC) and the Urology Interagency any interested person may file written
5001 Campus Dr., College Park, MD Coordinating Committee (UICC) will comments with the Committees by
20740, 240–402–1421. hold a joint meeting on December 16, forwarding their statement to the
SUPPLEMENTARY INFORMATION:
2016. The subject of the meeting will be contact person listed on this notice. The
‘‘The Urologic Complications of statement should include the name,
I. Background Diabetes.’’ The meeting is open to the address, telephone number and when
mstockstill on DSK3G9T082PROD with NOTICES
We are announcing the availability of public. applicable, the business or professional
the draft CPG entitled ‘‘Compliance DATES: The meeting will be held on affiliation of the interested person.
Policy Guide Sec. 540.750 Use of The December 16, 2016; from 9:00 a.m. to Because of time constraints for the
Seafood List to Determine Acceptable 12:00 p.m. Individuals wanting to meeting, oral comments will be allowed
Seafood Names.’’ The draft CPG, if present oral comments must notify the on a first-come, first-serve basis.
finalized, will update the previously contact person at least 10 days before Members of the public who would
issued ‘‘CPG Sec. 540.750—Common or the meeting date. like to receive email notification about
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Document Created: 2018-02-14 08:32:19
Document Modified: 2018-02-14 08:32:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Although you can comment on any CPG at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft CPG before we begin work on the final version of the CPG, submit either electronic or written comments on the draft CPG by January 17, 2017. | |
| Contact | Spring C. Randolph, Center for Food Safety and Applied Nutrition (HFC-325), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1421. | |
| FR Citation | 81 FR 81785 |
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